New FDA User Fee agreement

4 September 2017

By Dr Nicola Davies

On August 18, 2017, US President Donald Trump signed into law the Food and Drug Administration Reauthorization Act (FDARA) of 2017, extending the user fee program that was to expire on September 30, 2017.1 This legislation includes the Prescription Drug User Fee Amendments of 2017 (PDUFA VI) and the General Drug User Free Amendments (GDUFA).

What is the FDARA 2017?

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